Generic entry timeline

Vancocin generics — when can they launch?

Vancocin (vancomycin) · ANI Pharmaceuticals · 5 active US patents · 0 expired

Earliest patent expiry
2035-11-06
9 years remaining
Full patent estate to
2035-11-06
complete protection through 2035
FDA approval
—
ANI Pharmaceuticals

Where Vancocin sits in the generic timeline

Long-dated protection: earliest active US patent for Vancocin extends to 2035 (~9 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.

Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.

Patent estate by type — active patents

Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.

  • Method of Use — 3 patents
  • Formulation — 2 patents

FDA U-codes carved out by Vancocin patents

Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.

U-codeDescription
U-282(no description)

Sample patent estate

Showing 5 of 5 active US patents. View full estate on the Vancocin drug page →

  • US10039804 Method of Use · expires 2035-11-06
    This patent protects methods of manufacturing and using stable glycopeptide antibiotic solutions, such as those containing Vancomycin.
    USPTO title: Glycopeptide compositions
  • US11517609 Method of Use · expires 2035-11-06
    This patent protects methods of manufacturing and using stable glycopeptide antibiotic solutions, such as those containing Vancomycin, for pharmaceutical use.
    USPTO title: Glycopeptide compositions
  • US10849956 Formulation · expires 2035-11-06
    This patent protects stable solutions of glycopeptide antibiotics, such as Vancomycin, formulated with amino acids or derivatives for pharmaceutical use.
    USPTO title: Glycopeptide compositions
  • US11000567 Formulation · expires 2035-11-06
    This patent protects stable glycopeptide antibiotic solutions, such as those containing Vancomycin, for long-term use and storage.
    USPTO title: Glycopeptide compositions
  • US10188697 Method of Use · expires 2035-11-06
    This patent protects methods of manufacturing and using stable glycopeptide antibiotic solutions, such as those containing Vancomycin, for pharmaceutical use.
    USPTO title: Glycopeptide compositions

Sources

Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.

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